BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAP PRDGM INS V2.1 PL EN

    MDR report key: 1050271 · Received May 22, 2008

    Report

    Report Number
    2032227-2008-00879
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVELS OVER 500 MG/DL. THE CUSTOMER STATED THAT SHE ALSO HAD CHEST PAIN. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY, BUT THE CUSTOMER DID NOT CHANGE THE INFUSION SET. THE CUSTOMER CONTINUED TO BOLUS AND DID NOT RECEIVE THE ALARM AGAIN. THE CUSTOMER FELT UNCOMFORTABLE WITH THE INSULIN PUMP AND ASKED TO HAVE IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization